510(k) K232017 ยท LAO Enzyme Immunoassay, Methotrexate
ARK Methotrexate II Assay
| Applicant | Ark Diagnostics, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Dec 20, 2023 |
| Received | Jul 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232017
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.